FDA-Device2018-06-13Class II
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
NordicNeuroLab AS
Hazard
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
Sold states
USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
Affected count
22 licenses
Manufactured in
Mollendalsveien 65c, N/A, Bergen, N/A, Norway
Products
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2018Don't want to check this manually?
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